Prostate Cancer Clinical Trial
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
Summary
Study CP-MGC018-03 is a randomized, open-label, seamless, Phase 2/3 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT) and one prior taxane-containing regimen. ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior cabazitaxel regimen, but no other chemotherapy agents.
The Phase 2 stage will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg Q4W and 2.7 mg/kg Q4W) compared to the control arm (abiraterone or enzalutamide). Approximately 150 participants will be randomized 1:1:1 in Phase 2 among the three study treatment arms (two vobramitamab duocarmazine experimental arms and one control arm). An interim analysis will be performed to select the Phase 3 dose regimen for the vobramitamab duocarmazine experimental arm for Phase 3 after approximately 150 participants enrolled in Phase 2 have been followed for at least 2 months (60 days).
The Phase 3 stage will assess efficacy of the selected dose regimen for the vobramitamab duocarmazine experimental arm versus the control arm (abiraterone or enzalutamide). Approximately 270 additional participants will be randomized 1:1 between each study treatment arm in Phase 3 (one vobramitamab duocarmazine experimental arm and the control arm).
Eligibility Criteria
Inclusion Criteria:
Part 1 only: Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamous NSCLC, or SCLC.
Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of <60 days used as bridging to lutetium-177 is permitted.
Part 2 only: At least 1 prior line of systemic therapy for unresectable or metastatic disease and no more than 2 prior lines of cytotoxic chemotherapy. Participants with HNSCC or melanoma must have received prior PD-1 or PD-L1 inhibitor for advanced or metastatic disease.
All participants must have ≥ 1 metastatic lesion, according to RECIST 1.1 or PCWG3 criteria, that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
All participants must have tumor progression, according to disease-specific criteria, following their most recent anti-cancer therapy.
All participants must have and available archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
All participants have acceptable physical condition and laboratory values.
All participants of childbearing potential must agree to use highly effective methods of birth control.
All participants must not be pregnant, planning to be pregnant, or breastfeeding.
Exclusion Criteria:
Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
Part 1 only: Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of <60 days used as bridging for lutetium-177 is permitted.
Part 1 only: Received >3 total prior therapies for mCRPC
Part 1 only: Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
Untreated, symptomatic central nervous system (CNS) metastasis.
Prior treatment with any B7-H3 targeted agent for cancer,
Contradictions to the use of corticosteroid treatment
Prior stem cell, tissue, or solid organ transplant.
Part 1 only: Use of products that have published anti-prostate cancer activity or are known to decrease PSA.
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There are 61 Locations for this study
Fountain Valley California, 92708, United States
Los Angeles California, 90095, United States
Jacksonville Florida, 32209, United States
Orange City Florida, 32763, United States
Covington Louisiana, 70433, United States
Baltimore Maryland, 21231, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55455, United States
Canton Ohio, 44718, United States
Portland Oregon, 97239, United States
Myrtle Beach South Carolina, 29572, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98109, United States
Westmead New South Wales, 2145, Australia
Woolloongabba Queensland, 4102, Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3000, Australia
Woluwe-Saint-Lambert Brussles, 1200, Belgium
Charleroi Hainaut, 6000, Belgium
Libramont Luxembourg, 6800, Belgium
Godinne Namur, 5300, Belgium
Gent , 9000, Belgium
Nice Cedex 2 AM, 06189, France
Strasbourg Bas Rhin, 67200, France
Bordeaux Gironde, 33076, France
Montpellier Herault, 34298, France
Saint-Mandé Ile De France, 94160, France
Suresnes Ile De France, 92150, France
Saint-Grégoire Ille Et Vilaine, 35760, France
Le Mans Sarthe, 72000, France
Villejuif Val De Marne, 94800, France
Brest , 29200, France
Paris , 75014, France
Orbassano TO, 10049, Italy
Mestre Venice, 30174, Italy
Florence , 50134, Italy
Padova , 35128, Italy
Trento , 38122, Italy
Bugok Daegu, 41404, Korea, Republic of
Goyang Kyonggi, 10408, Korea, Republic of
Gwangju , 61469, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 07985, Korea, Republic of
Seoul , 5505, Korea, Republic of
Otwock Mazowieckie, 05-40, Poland
Warszawa Mazowieckie, 01-74, Poland
Warszawa Mazowieckie, 02-79, Poland
Warszawa Mazowieckie, 04-07, Poland
Konin Wlkp, 62-50, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
Sabadell Barcelona, 08208, Spain
Sevilla Seville, 41013, Spain
Barcelona , 08003, Spain
Barcelona , 08036, Spain
Barcelona , 08036, Spain
Lugo , 27002, Spain
Madrid , 28041, Spain
Sutton Surrey, SM2 5, United Kingdom
Oxford , OX3 7, United Kingdom
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